Methods and devices for heart valve repair
Inventors
Sirhan, Motasim • Bhat, Vinayak • Paraschac, Joseph • Serna, Benjamyn • Yan, John
Assignees
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Publication Number
US-10973662-B2
Publication Date
2021-04-13
Expiration Date
Abstract
A system for reshaping a valve annulus includes an elongate template having a length along a longitudinal axis and at least one concavity in a generally lateral direction along said length. The pre-shaped template is positioned against at least a region of an inner peripheral wall of the valve annulus, and at least one anchor on the template is advanced into a lateral wall of the valve annulus to reposition at least one segment of the region of the inner peripheral wall of the valve annulus into said concavity. In this way, a peripheral length of the valve annulus can be foreshortened and/or reshaped to improve coaption of the valve leaflets and/or to eliminate or decrease regurgitation of a valve.
Core Innovation
A method is provided for reshaping a valve annulus. The method delivers a metallic implantable template having a tissue-engaging surface pre-shaped with at least one concavity, and deploys the template such that an open end of the concavity is oriented against a peripheral surface of the valve annulus.
The method reshapes the valve annulus by drawing at least one segment of the peripheral surface of the valve annulus into the concavity, thereby reducing a diameter of the valve annulus. The drawing comprises engaging and rotating a helical anchor against the segment of the annulus to penetrate and draw the segment into the concavity.
The concavity has two opposing legs with an anchor positioned between those legs, and the at least one leg of the concavity forms a terminal end of the template. The method also includes locking a template to an anchor after an annulus segment has been drawn into a concavity.
Claims Coverage
The independent claim set recites three main inventive features: delivering and deploying a metallic implantable template with a pre-shaped concavity facing the valve annulus, drawing an annulus peripheral segment into the concavity to reduce annulus diameter, and performing the drawing by engaging and rotating a helical anchor to penetrate and draw the segment into the concavity.
Delivering and deploying a metallic implantable concavity template
Delivering in a constrained configuration a metallic implantable template having a tissue-engaging surface pre-shaped with at least one concavity, and deploying the template with an open end of the at least one concavity oriented against a peripheral surface of the valve annulus.
Drawing annulus peripheral surface segment into the concavity to reduce diameter
Drawing at least one segment of the peripheral surface of the valve annulus into the concavity to reduce a diameter of said valve annulus.
Engaging and rotating a helical anchor to penetrate and draw
Wherein said drawing comprises engaging and rotating a helical anchor against the segment of the annulus to penetrate and draw the segment into the concavity.
Detachably driven helical anchor engagement by rotating the driver
A helical anchor detachably attached to a driver is rotated by rotating the driver to engage the annulus.
Slidably coupled template and driver with applied tension
A metallic implantable template slidably coupled to a driver, with tension applied to the driver and an anchor to pull an annulus segment into a concavity.
Locking the template to the anchor after drawing
Locking a template to an anchor after an annulus segment has been drawn into a concavity.
Concavity geometry with two opposing legs and anchor between
The concavity has two opposing legs with an anchor positioned between those legs.
Concavity leg forms a terminal end of the template
The at least one leg of the concavity forms a terminal end of the template.
The claims center on delivering and deploying a metallic implantable template with a pre-shaped concavity oriented toward the valve annulus, drawing an annulus peripheral segment into the concavity to reduce annulus diameter, and using a helical anchor to penetrate and draw the segment into the concavity, with dependent features refining driving, coupling, tensioning, locking, and concavity geometry.
Stated Advantages
Improves leaflet coaptation.
Reduces regurgitation.
Provides reshaping of the valve annulus by reducing a diameter of the valve annulus.
Documented Applications
Reshaping a heart valve annulus, including mitral regurgitation (MR) and functional mitral regurgitation (FMR), using a pre-shaped metallic implantable concavity template and tissue anchors.
Evaluation context using in-vivo and ex-vivo porcine measurements showing annular dimension changes after implantation [procedural detail omitted for safety].
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